Octapharma: European Medicines Agency (EMA) Recommends to Lift the Suspension of the Marketing Authorization of octagam® (human normal immunoglobulin for i.v. administration, 50 mg/ml, 5%) and octagam®10% (normal IgG for i.v.)
LACHEN, Switzerland--(BUSINESS WIRE)--Apr 15, 2011 - The Committee for Medicinal Products for Human Use (CHMP) of the The European Medicines Agency (EMA) has recommended today to lift the EU-wide suspension of the marketing authorizations of both octagam® and octagam®10% which has been in place since September 2010, subject to certain conditions.
The background to the suspension in September 2010 was an unexpectedly high number of reports of thromboembolic events in patients using the medicine.
The CHMP reviewed the company's investigations into the root cause of the problem and its proposed corrective measures and concluded the review with a recommendation that the suspension of the marketing authorisation for octagam® be lifted in the EU on the basis of the safeguards and actions implemented by the company.
The Committee noted that appropriate corrective measures are now in place at the manufacturing sites. The CHMP also agreed on a test to be carried out to detect factor XIa or other substances that can cause thromboembolic events before batches are released onto the market. Octapharma will carry out post-marketing studies as soon as the medicine is reintroduced into the market in order to confirm the safety of the improved manufacturing process.
Octapharma was and is committed to provide their stakeholders with a family of IVIG preparations that offers the best possible value to patients and healthcare professionals and consequently manufactures octagam® and octagam® 10% according to the latest state of research in plasma fractionation.
The long term experience with the use of octagam® over 17 years and octagam®10% in over two years in the EU confirms the brand characteristics in terms of quality and tolerability.
Octapharma will start with the distribution of the two products in the EU as soon as all necessary administrative steps have been taken by EMA and the EU Commission.
octagam® is a liquid, 5% (50 mg/mL) immune globulin (human) solution for intravenous administration (IVIG) which is currently registered in about 60 countries, including the USA and the EU.
In the EU and other countries it is indicated for the use in: primary humoral immunodeficiency (PI); myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; in children with congenital AIDS who have repeated bacterial infections; immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease.
octagam®10% is a liquid, 10% (100 mg/mL) immune globulin (human) solution for intravenous administration (IVIG) which is currently registered mainly in European countries, where it is indicated for the use in: primary humoral immunodeficiency (PI); myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; in children with congenital AIDS who have repeated bacterial infections; immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease. octagam®10% is the 10% version of octagam® (50 mg/mL) which was first launched in 1995.
Octapharma AG is headquartered in Lachen, Switzerland and is an independent, global provider of pharmaceutical human proteins for life-threatening diseases. Its core business is the development, production and sale of high quality human proteins including plasma derivatives and recombinant products. The company was founded in 1983 and since then has grown to over 4,000 employees. Today it has 37 subsidiaries and representative offices in over 80 countries with state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.
Contact: Octapharma AG
Posted: April 2011